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HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer

Primary Purpose

Biochemical Relapse Free Survival, Complications Rates (Erectile Dysfunction, GI, GU Complications)

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Stereotactic ablative radiotherapy
High dose rate brachytherapy
Sponsored by
N.N. Petrov National Medical Research Center of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biochemical Relapse Free Survival focused on measuring brachytherapy, stereotactic ablative radiotherapy, survival, complications

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • WHO performance status of 0-2,
  • histologically confirmed prostate adenocarcinoma: Gleason score - 6-7 (4+3), clinical stage T1c-T2c, N0, M0
  • T and N stage determined by clinical examinations, MRI and/or PET-CT with PSMA
  • PSA below 20 ng/ml within the last 30 days
  • international prostate index score (IPSS) below 16
  • medically fit to spinal anesthesia
  • prostate volume below 110 cm³
  • maximal urinary rate above 9 ml/sec, residual urine volume below 30ml,
  • in the case of previous transurethral resection interval of at least 9 months after procedure.

Exclusion Criteria:

  • stage T3-T4,
  • PSA > 20 ng/ml,
  • clinically detected lymph node or distant metastases,
  • previous pelvic irradiation,
  • rectal surgery.

Sites / Locations

  • Sergey NovikovRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High dose rate brachytherapy

Stereotactic ablative radiotherapy

Arm Description

After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2).

Before SBRT three fiducial markers are obligatory inserted into the prostate.Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm³ for bladder, V 20 Gy <10 cm³ for femoral heads. Androgen deprivation therapy is not permitted. All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.

Outcomes

Primary Outcome Measures

Number of grade 3-5 Adverse Events Assessed by Common Terminology Criteria for Adverse Events CTCAE v5
To evaluate frequency of grade 3-5 toxicity in patients treated by high dose rate brachutherapy (arm 1) and stereotactic ablative radiotherapy (arm 2)
Change in the proportion of patients with moderate and severe erectile dysfunction
Assessed by International Index of Erectile Function (IIEF)

Secondary Outcome Measures

Biochemical relapse free survival
PSA levels in the blood. Reccurence - nadir + 2 ng/ml

Full Information

First Posted
March 29, 2021
Last Updated
April 28, 2021
Sponsor
N.N. Petrov National Medical Research Center of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT04870567
Brief Title
HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer
Official Title
High Dose Rate Brachytherapy vs Stereotactic Ablative Body Therapy in Patients With Early-intermediate Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high dose rate brachytherapy (HDRB) for localized low- and intermediate risk prostate cancer patients.
Detailed Description
Before SBRT three fiducial markers are obligatory inserted into the prostate. Simulation and every SBRT sessions are performed after bowel preparation (enema) and bladder filling (400ml).Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. The clinical target volume (CTV) include the prostate only (low-risk patients) or prostate and proximal 1/3 of seminal vesicles (intermediate-risk patients). CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm³ for bladder, V 20 Gy <10 cm³ for femoral heads. Androgen deprivation therapy is not permitted. All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional. After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2). Patients are assessed during treatment, 4-12 weeks after the end of the treatment, every 3 months for the first year and then every 6 months till the end of the study. Normal tissue adverse events are reported according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). International prostate symptoms score (IPSS) and international index of erectile function (IIEF-5) must be assessed on each visit, maximal urinary rate and residual urine volume - annually.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biochemical Relapse Free Survival, Complications Rates (Erectile Dysfunction, GI, GU Complications)
Keywords
brachytherapy, stereotactic ablative radiotherapy, survival, complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose rate brachytherapy
Arm Type
Active Comparator
Arm Description
After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 < 110% , rectum D2cc<75% (below 75Gy EQD2).
Arm Title
Stereotactic ablative radiotherapy
Arm Type
Experimental
Arm Description
Before SBRT three fiducial markers are obligatory inserted into the prostate.Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy <5 cm³ for bladder, V 20 Gy <10 cm³ for femoral heads. Androgen deprivation therapy is not permitted. All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic ablative radiotherapy
Intervention Description
Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).
Intervention Type
Radiation
Intervention Name(s)
High dose rate brachytherapy
Intervention Description
Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).
Primary Outcome Measure Information:
Title
Number of grade 3-5 Adverse Events Assessed by Common Terminology Criteria for Adverse Events CTCAE v5
Description
To evaluate frequency of grade 3-5 toxicity in patients treated by high dose rate brachutherapy (arm 1) and stereotactic ablative radiotherapy (arm 2)
Time Frame
5 years after treatment
Title
Change in the proportion of patients with moderate and severe erectile dysfunction
Description
Assessed by International Index of Erectile Function (IIEF)
Time Frame
3, 6, 12, 18, 24 and every 6 months through 5 years
Secondary Outcome Measure Information:
Title
Biochemical relapse free survival
Description
PSA levels in the blood. Reccurence - nadir + 2 ng/ml
Time Frame
5 years after treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer can be detected only in male patients
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: WHO performance status of 0-2, histologically confirmed prostate adenocarcinoma: Gleason score - 6-7 (4+3), clinical stage T1c-T2c, N0, M0 T and N stage determined by clinical examinations, MRI and/or PET-CT with PSMA PSA below 20 ng/ml within the last 30 days international prostate index score (IPSS) below 16 medically fit to spinal anesthesia prostate volume below 110 cm³ maximal urinary rate above 9 ml/sec, residual urine volume below 30ml, in the case of previous transurethral resection interval of at least 9 months after procedure. Exclusion Criteria: stage T3-T4, PSA > 20 ng/ml, clinically detected lymph node or distant metastases, previous pelvic irradiation, rectal surgery.
Facility Information:
Facility Name
Sergey Novikov
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Novikov
Phone
+7-9500437996
Email
krokon@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer

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